Effects of Insoles on Children With Developmental Delays
- Conditions
- Developmental Delay
- Registration Number
- NCT03191006
- Lead Sponsor
- Taipei Medical University
- Brief Summary
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
- Detailed Description
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).
The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.
The control group will be evaluated at the baseline and up to 12 weeks.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
- developmental delays
- age less than 3 years old or older than 10 years old normal development
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change from baseline functional performance (scores) at 12 weeks baseline and up to 12 weeks Pediatric Outcome Data Collection Instrument
- Secondary Outcome Measures
Name Time Method change from baseline balance (scores) at 12 weeks baseline and up to 12 weeks Berg balance scale
change from baseline physical function (time) at 12 weeks baseline and up to 12 weeks time of stair climbing, timed up and go, walking on level ground
change from baseline quality of life at 12 weeks baseline and up to 12 weeks Pediatric Quality of Life inventory (PedsQL)
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital🇨🇳Taipei, Taiwan